Virtual Mentor. September 2011, Volume 13, Number 9: 626-628.
THE CODE SAYS
The AMA Code of Medical Ethics’ Opinions on Patient Safety
The AMA Code of Medical Ethics' opinions on patient safety.
Opinion 8.12 - Patient Information
It is a fundamental ethical requirement that a physician should at all times deal honestly and openly with patients. Patients have a right to know their past and present medical status and to be free of any mistaken beliefs concerning their conditions. Situations occasionally occur in which a patient suffers significant medical complications that may have resulted from the physician’s mistake or judgment. In these situations, the physician is ethically required to inform the patient of all the facts necessary to ensure understanding of what has occurred. Only through full disclosure is a patient able to make informed decisions regarding future medical care.
Ethical responsibility includes informing patients of changes in their diagnoses resulting from retrospective review of test results or any other information. This obligation holds even though the patient’s medical treatment or therapeutic options may not be altered by the new information.
Concern regarding legal liability which might result following truthful disclosure should not affect the physician’s honesty with a patient.
Report issued March 1981; updated June 1994.
Opinion 8.121 - Ethical Responsibility to Study and Prevent Error and Harm
In the context of health care, an error is an unintended act or omission, or a flawed system or plan, that harms or has the potential to harm a patient. Patient safety can be enhanced by studying the circumstances surrounding health care errors. This can best be achieved through a legally protected review process, which is essential for reducing health care errors and preventing patient harm.
Report issued December 2003, based on Ethical Responsibility to Study and Prevent Error and Harm in the Provision of Health Care, adopted June 2003.
Opinion 9.032 - Reporting Adverse Drug or Device Events
A physician who suspects the occurrence of an adverse reaction to a drug or medical device has an obligation to communicate that information to the broader medical community, (e.g., through submitting a report or letter to a medical journal or informing the manufacturer of the suspect drug or device). In the case of a serious adverse event, the event should be reported to the Food and Drug Administration (FDA). Spontaneous reports of adverse events are irreplaceable as a source of valuable information about drugs and medical devices, particularly their rare or delayed effects, as well as their safety in vulnerable patient populations. Although premarketing and mandated postmarketing studies provide basic safeguards for the public health, they suffer from inherent deficiencies that limit their ability to detect rare or unexpected consequences of drug or medical device use. Physicians who prescribe and monitor the use of drugs and medical devices constitute the group best able to observe and communicate information about resulting adverse events.
Serious adverse events, such as those resulting in death, hospitalization, or medical or surgical intervention, are the most important to report and are the only adverse events for which the FDA desires a report. Certainty, or even reasonable likelihood, of a causal relationship between the drug or medical device and the serious adverse event will rarely exist and is not required before reporting the event to the FDA. Suspicion of such a relationship is sufficient to give rise to an obligation to participate in the reporting system.
Report issued June 1993, based on Reporting Adverse Drug and Medical Device Events, adopted June 1993; updated June 1994.
Opinion 9.14 - Quality
As professionals dedicated to promoting the well-being of patients, physicians individually and collectively share the obligation to ensure that the care patients receive is safe, effective, patient centered, timely, efficient, and equitable.
While responsibility for quality of care does not rest solely with physicians, their role is essential. Individually and collectively, physicians should actively engage in efforts to improve the quality of health care by:
Issued November 2009, based on Quality adopted June 2009.
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